Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Lucentis

• Registration Number: NCT03097068
• Lead Sponsor: Vitreo-Retinal Associates, Michigan

Brief Summary

The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.

Detailed Description

Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.

Study Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-31
• Study Start: 2017-04-19
• Primary Completion: 2017-12-06
• Study Completion: 2018-02-02
• Results First Submitted: 2022-05-04
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-21
• Last Update Submitted: 2022-10-21
• Results First Posted: 2022-10-24
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Diagnosis of diabetes mellitus
• Best corrected visual acuity 20/32 - 20/320
• Diabetic macular edema involving the center of the macula
• Optical coherence tomography central subfield thickness of at least 250 microns

Exclusion Criteria

• History of anti-vascular endothelial growth factor treatment in the past 12 months
• Any diabetic macular edema treatment in the past 4 months
• Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.3 mg Lucentis	Lucentis	Aqueous Humor sample post injection of 0.3 mg Lucentis

Primary Outcome Measures

Name	Time	Method
Vascular Endothelial Growth Factor Levels	12 weeks	An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment.

Trial Locations

Locations (1)

Vitreo-Retinal Associates; 🇺🇸 Grand Rapids, Michigan, United States